Method, system and use for therapeutic ultrasound

ABSTRACT

The described embodiments relate to methods, systems and uses for therapeutic ultrasound, and in particular, to methods, systems and uses for therapeutic ultrasound for treating or alleviating eye conditions. The described embodiments relate to methods, systems and uses that involve an ultrasound device configured for treatment of an eye condition, where the device comprises at least one ultrasound transducer for coupling to at least a portion of an eyelid to supply ultrasound waves to an area proximate to the portion of the eyelid according to treatment parameters, wherein the treatment parameters comprise a treatment frequency and a treatment period.

FIELD

The described embodiments relate to methods, systems and uses fortherapeutic ultrasound, and in particular, to methods, systems and usesfor therapeutic ultrasound for treating or alleviating eye conditions.

INTRODUCTION

Eye conditions may relate to meibomian gland dysfunction. Dry eye is amultifactorial disease of epidemic proportions. For example, whenextrapolating National Health Services data to the Canadian population,more than 500,000 Canadians may suffer from moderate to severe dry eye.Dry eye can be categorized into two broad categories: aqueous deficientdry eye and evaporative dry eye. Leading experts now speculate that asmuch as 80% of dry eye may be caused by meibomian gland dysfunction.With blockage of the eyelid meibomian glands and ducts there may be areduction of lipids within the tear film. This results in instability ofthe tear film with subsequent early tear break up and evaporation. Thisultimately leads to exposure of the corneal surface and a cascade ofocular surface inflammation, thus perpetuating a dysfunctional tearsyndrome.

Another example eye condition is a chalazion or meibomian cyst which isa collection of oil or blockage of the meibomian gland and ducts. Afurther example of an eye condition is a hordeolum or stye which may bean inflamed sebaceous gland of Zeiss. Finally, an additional example isblepharitis which is an inflammation of the eyelid which may predisposesubjects to aforementioned eye conditions, such as dry eye, chalazion,hordeolum. Other eye conditions include scarring.

There is a need for improved methods, systems and uses for treating oralleviating eye conditions, such as those associated with the meibomiangland and ducts.

SUMMARY

In a first aspect, embodiments described herein provide a use of anultrasound device for treatment of an eye condition, wherein the devicecomprises at least one ultrasound transducer for coupling to at least aportion of an eyelid to supply ultrasound waves to an area proximate tothe portion of the eyelid according to treatment parameters.

In some embodiments, the treatment parameters comprise a frequency, anamplitude, on/off cycle, and a treatment period. In some embodiments,the treatment frequency is at least 2 MHz, at least 3 MHz, or between 3to 5 MHz, or even greater than 5 MHz. In some embodiments, the treatmentperiod is between two to five minutes. These are non-limiting examples.The on/off cycle may be used to pulse the ultrasound waves.

In some embodiments, the device further comprises a controller operablefor receiving treatment data, determining the treatment parameters basedon the treatment data, and directing the ultrasound transducer accordingto the treatment parameters.

In some embodiments, the eye condition is caused by dysfunction of themeibomian glands and wherein the area proximate to the portion of theeyelid comprises the meibomian glands and its ductules. In someembodiments, the eye condition is caused by dysfunction of the lacrimalglands and wherein the area proximate to the portion of the eyelidcomprises the lacrimal glands and ductules. In some embodiments, the eyecondition is caused by dysfunction of the periocular glands and whereinthe area proximate to the portion of the eyelid comprises the periocularglands and ductules. In some embodiments, the eye condition is caused bydysfunction of the nasolacrimal system and wherein the area proximatecomprises the nasolacrimal system. In some embodiments, the eyecondition is caused by dysfunction of the Wolfring glands and whereinthe area proximate to the portion of the eyelid comprises the Wolfringglands and ductules. In some embodiments, the eye condition is caused bydysfunction of the Krause glands and wherein the area proximate to theportion of the eyelid comprises the Krause glands and ductules. In someembodiments, the eye condition is caused by dysfunction of the Zeisglands and wherein the area proximate to the portion of the eyelidcomprises the Zeis glands and ductules.

In some embodiments, the eye condition is caused by lipids blocked inone or more glands of the eye and wherein the ultrasound waves heat thelipids to emulsify the lipids blocked in the glands and ductules andfacilitate flow. In some embodiments, the ultrasound waves heat thelipids to approximately 40 degrees Celsius to increase flow and mobilityof the lipids. This is a non-limiting example. In some embodiments, theultrasound waves supply oscillations to move the emulsified lipids bycreating bubbles in the emulsified lipids. In some embodiments, theultrasound waves supply acoustic streaming to mobilize the emulsifiedlipids. In some embodiments, the ultrasound waves cause mircocavitationto mobilize the emulsified lipids. In some embodiments, the ultrasoundwaves stimulate circulation and lymph flow in the area proximate to theportion of the eyelid.

In some embodiments, the ultrasound waves breakdown scar tissue in thearea proximate to the portion of the eyelid.

In some embodiments, the ultrasound waves supply continuous ultrasoundenergy. In some embodiments, the ultrasound waves supply pulsedultrasound energy defined by on/off cycle.

In some embodiments, the device further comprises a probe for couplingto the ultrasound transducer.

In some embodiments, the device is configured to provide phased arrayultrasound to vary ultrasound waves.

In some embodiments, the ultrasound transducer comprises movablecomponents that are configured to move relative to the portion of theeyelid to vary ultrasound waves.

In some embodiments, the device comprises an ultrasound imaging cameraand wherein the device is operable in a therapeutic mode to heat thearea proximate to the portion of the eyelid and a diagnostic mode toimage the area proximate to the portion of the eyelid using theultrasound imaging camera. In some embodiments, the device can operatein therapeutic mode and diagnostic mode to perform real-time imagingduring treatment.

In some embodiments, the ultrasound transducer has a concave shape tocomplement the eyelid, or the ultrasound transducer has an attachmentwith a concave shape to complement the eyelid. In some embodiments, theultrasound transducer has an elliptical shape to complement the eyelid.In some embodiments, the device further comprises an attachment for theultrasound transducer, wherein the attachment comprises a protectiveportion for positioning over the eye globe and under the eyelid toprotect eye tissue, wherein the protective portion has a concave shapeto complement the eyelid.

In some embodiments, the eye condition is selected from the groupconsisting of dry eye, meibomian gland dysfunction, duct dysfunction,lacrimal gland dysfunction, periocular gland dysfunction, nasolacrimalsystem dysfunction, post-surgical scarring, and chalazion.

In another aspect, embodiments described herein provide use of anultrasound device configured for treatment of dry eye, wherein thedevice comprises at least one ultrasound transducer for coupling to atleast a portion of an eyelid to supply ultrasound waves to an areaproximate to the lacrimal glands to stimulate aqueous production andflow from the lacrimal glands and ducts.

In another aspect, embodiments described herein provide the use of ahigh frequency ultrasound device configured for treatment of dry eye,wherein the device comprises at least one ultrasound transducer forcoupling to at least a portion of an eyelid to supply ultrasound wavesto an area proximate to the meibomian gland to stimulate aqueousproduction and flow from the meibomian gland and ducts.

In a further aspect, embodiments described herein provide a system fortreating an eye condition comprising: an ultrasound device comprising atleast one ultrasound transducer for coupling to at least a portion of aneyelid to supply ultrasound waves to an area proximate to the portion ofthe eyelid according to treatment parameters. In some embodiments, thetreatment parameters comprise a frequency, an amplitude, on/off cycle,and a treatment period. Example frequency ranges include at least 2 MHz,at least 3 MHz, and between 3 to 5 MHZ. Greater than 5 MHZ frequenciesmay also be used to limit depth of penetration into tissue. An exampletreatment period is between two to five minutes. These are non-limitingexamples.

In some embodiments, the system further comprises a controller operablefor receiving treatment data from an external source, determining thetreatment parameters based on the treatment data, and directing theultrasound transducer according to the treatment parameters.

In some embodiments, the ultrasound waves heat the area proximate to theportion of the eyelid

In some embodiments, the eye condition is caused by lipids blocked in agland or duct of the eye and wherein the ultrasound waves heat the areaproximate to the portion of the eyelid to emulsify the lipids blocked inthe gland or the duct and facilitate flow. In some embodiments, theultrasound waves heat the lipids to approximately 40 degrees Celsius. Insome embodiments, the ultrasound waves supply oscillations to move theemulsified lipids by creating bubbles in the emulsified lipids. In someembodiments, the ultrasound waves supply acoustic streaming to mobilizethe emulsified lipids. In some embodiments, the ultrasound waves causemircocavitation to mobilize the emulsified lipids. In some embodiments,the ultrasound waves stimulate circulation and lymph flow in the areaproximate to the portion of the eyelid. In some embodiments, theultrasound waves breakdown scar tissue in the area proximate to theportion of the eyelid. In some embodiments, the ultrasound waves supplycontinuous ultrasound energy. In some embodiments, the ultrasound wavessupply pulsed ultrasound energy.

In some embodiments, the device further comprises a probe for couplingto the ultrasound transducer. In some embodiments, the device isconfigured to provide phased array ultrasound. In some embodiments, theultrasound transducer comprises movable components that are configuredto move relative to the portion of the eyelid to vary ultrasound waves.In some embodiments, the device comprises an ultrasound imaging cameraand wherein the device is operable in a therapeutic mode to heat thearea proximate to the portion of the eyelid using the ultrasound wavesand a diagnostic mode to image the area proximate to the portion of theeyelid using the ultrasound imaging camera. In some embodiments, theultrasound transducer has a concave shape to complement the eyelid. Insome embodiments, ultrasound transducer has an elliptical shape tocomplement the eyelid. In some embodiments, the device further comprisesan attachment for the ultrasound transducer, wherein the attachmentcomprises a protective portion for positioning over the eye globe andunder the eyelid to protect eye tissue, wherein the protective portionhas a concave shape to complement the eyelid. In some embodiments, theeye condition is selected from the group consisting of dry eye,meibomian gland dysfunction, duct dysfunction, lacrimal glanddysfunction, periocular gland dysfunction, nasolacrimal systemdysfunction, post-surgical scarring, and chalazion.

In some embodiments, the system may further comprise a roller shaped tocomplement the eyelid and applied to the eyelid to express theemulsified lipids from the gland or the duct. In some embodiments, thesystem may further comprise a contact lens to protect ocular tissuearound the eye. The lens may be a vaulted scleral contact lensconfigured for placement over the eye globe and under the eyelid to forma chamber of air between the posterior surface of the contact lens andthe cornea. The lens may comprise an absorptive material to blockpenetration of ocular tissue by the ultrasound waves. In someembodiments, the system may further comprise a lens speculum to elevatethe eyelid from the eye globe and create airspace between eye globe andeyelid. In some embodiments, the system may further comprise atemperature measurement mechanism for measuring the temperature of thearea proximate to the portion of the eyelid. In some embodiments, thesystem may further comprise the temperature measurement mechanismcomprises a thermal couple. In some embodiments, the system may furthercomprise a contact lens to protect ocular tissue around the eye, whereinthe thermal couple is positioned on the contact lens. In someembodiments, the system may further comprise an ultrasound measurementmechanism for measuring the ultrasounds waves at the area proximate tothe portion of the eyelid.

In a further aspect, embodiments described herein provide a method fortreating an eye condition using a therapeutic ultrasound device, themethod comprising: coupling at least one ultrasound transducer to atleast a portion of an eyelid; and propagating ultrasound waves to anarea proximate to the portion of the eyelid using the ultrasoundtransducer according to treatment parameters.

In some embodiments, the treatment parameters comprise a frequency, anamplitude, on/off cycle, and a treatment period. In some embodiments,the method may further comprise placing a contact lens over the eyeglobe and under the eyelid to protect ocular tissue around the eye. Insome embodiments, the lens is a vaulted scleral contact lens configuredto form a chamber of air between the posterior surface of the contactlens and the cornea. In some embodiments, the lens comprises anabsorptive material to block penetration of ocular tissue by theultrasound waves. In some embodiments, the method may involve using alens speculum to elevate the eyelid from the eye globe and create anairspace between eye globe and eyelid. In some embodiments, the eyecondition relates to the meibomian glands and wherein the ultrasoundwaves are supplied for the treatment period to liquefy solidified fatsin the meibomian glands. In some embodiments, the eye condition relatesto the glands of Zeiss with a hordeolum present and wherein theultrasound waves are supplied for the treatment period to liquefy fatsin the glands of Zeiss when the hordeolum is present.

In some embodiments, the method may further comprise applying ultrasoundgel to the surface of the eyelid to act as a coupling medium between eyetissue and the transducer.

In another aspect, embodiments described herein provide use of anultrasound device configured for treatment of meibomian glanddysfunction caused by solidified fats, wherein the device comprises atleast one ultrasound transducer for coupling to at least a portion of aneyelid to supply ultrasound waves to the meibomian glands and ductulesto heat the meibomian glands and ductules and liquefy the solidifiedfats.

In another aspect, embodiments described herein provide use of anultrasound device configured to promote remodeling and resolution ofeyelid scar tissue from the etiology selected from the group consistingof post-surgical, post chalazion, post-inflammatory, andpost-infectious, wherein the device comprises at least one ultrasoundtransducer for coupling to at least a portion of the eyelid to supplyultrasound waves to breakdown scar tissue in the eyelid. This treatmentcould be combined with topical steroids placed directly on the dermis ofthe eyelid within the coupling medium. The ultrasound energy couldfacilitate steroid penetration into the eyelid tissue.

In a further aspect, embodiments described herein provide The use of anultrasound device configured for treatment of an eye condition, whereinthe device is operable in a therapeutic mode and a diagnostic mode,wherein the device comprises at least one ultrasound transducer forcoupling to at least a portion of an eyelid to supply ultrasound wavesto an area proximate to the portion of the eyelid to diagnose the eyecondition in the diagnostic mode and to treat the eye conditionaccording to treatment parameters in the therapeutic mode.

In some embodiments, the ultrasound device is configured to operate indiagnostic mode and therapeutic mode concurrently to provide real-timeimaging during treatment.

In another aspect, embodiments described herein provide the use of anultrasound device configured to facilitate fluid flow down thenasolacrimal system, wherein the device comprises at least oneultrasound transducer for coupling to at least a portion of an innercanthal region of the eye to supply ultrasound waves to an areaproximate nasolacrimal system according to treatment parameters.

In another aspect, embodiments described herein provide the use of anultrasound device configured to break up stones within the nasolacrimalsystem, wherein the device comprises at least one ultrasound transducerfor coupling to at least a portion of an inner canthal region of the eyeto supply ultrasound waves to an area proximate nasolacrimal systemaccording to treatment parameters, wherein the treatment parameterscomprise a treatment frequency and a treatment period.

DRAWINGS

For a better understanding of embodiments of the systems, methods anduses described herein, and to show more clearly how they may be carriedinto effect, reference will be made, by way of example, to theaccompanying drawings in which:

FIG. 1 shows a diagram of a system for eye conditions using therapeuticultrasound according to some embodiments;

FIG. 2 shows a diagram of a meibomian gland according to someembodiments;

FIG. 3 shows a diagram of a use of therapeutic ultrasound for eyeconditions according to some embodiments;

FIG. 4 shows a diagram of a method using ultrasound for eye conditionsaccording to some embodiments;

FIG. 5 shows another diagram of a use of therapeutic ultrasound for eyeconditions according to some embodiments;

FIG. 6 shows a diagram of a use of therapeutic ultrasound with anattachment for eye conditions according to some embodiments; and

FIG. 7 shows another diagram of a use of therapeutic ultrasound with anattachment for eye conditions according to some embodiments.

The drawings, described below, are provided for purposes of illustrationof the aspects and features of various examples of embodiments describedherein. For simplicity and clarity of illustration, elements shown inthe figures have not necessarily been drawn to scale. The dimensions ofsome of the elements may be exaggerated relative to other elements forclarity. Further, where considered appropriate, reference numerals maybe repeated among the figures to indicate corresponding or analogouselements.

DESCRIPTION OF VARIOUS EMBODIMENTS

It will be appreciated that numerous specific details are set forth inorder to provide a thorough understanding of the exemplary embodimentsdescribed herein. However, it will be understood by those of ordinaryskill in the art that the embodiments described herein may be practicedwithout these specific details. In other instances, well-known methods,procedures and components have not been described in detail so as not toobscure the embodiments described herein. Furthermore, this descriptionshould be considered as describing implementation of the variousembodiments described herein.

The described embodiments relate to methods, systems and uses fortherapeutic ultrasound for treating or alleviating eye conditions, suchas dry eye and other conditions associated with gland dysfunction andeyelids.

Eye conditions may relate to meibomian gland dysfunction. For example,one of the underlying causes of dry eye may be meibomian glanddysfunction. Other example eye conditions include chalazion, meibomiancysts, hordeolum, stye, blepharitis and so on. Meibomian glanddysfunction may occur due to a variety of factors. These factors rangefrom keratinization of ductules, inflammation of ducts, solidificationof lipid secretions, and atrophy of glands themselves. A meibomian glandblockage, dry eye, and other eye conditions may be ameliorated withheat. The heat required to break up oil secretions involves a treatmentthat sufficiently warms the eyelid for a period of time. For example,heat treatment may warm the eyelids to 40 degrees Celsius for fourminutes. Hot water (wet towel) compresses may be used to apply wet heatto the eyelids. Although efficacious, patient compliance may be aproblem and the technique may be error prone as the compress may notwarm eyelids to sufficiently warm temperatures. As another treatmentapproach, a product Lipiflow™ may heat the eyelids and massage them tofacilitate expression of oil contents. Although efficacious thistreatment product may be costly and a transducer head may have to bepurchased for each patient.

The described embodiments relate to methods, systems and uses fortherapeutic ultrasound for eye conditions by providing heat andoscillatory ultrasound energy to the eyelids, meibomian glands, lacrimalgland, or other glands and areas proximate eye. By using therapeuticultrasound energy the depth of tissue penetration may be minimized whilethe amount of energy delivered to the tissue may be maximized.

For ultrasounds, the frequency used typically ranges from 1 to 3 MHzdepending on tissue depth penetration. A 1 MHz ultrasound is typicallyabsorbed at a tissue depth of 3-5 cm. A frequency of 3 MHz is used forsuperficial lesions at depths of 1-2 cm. Since the eyelid is onlyseveral millimeters in thickness a high frequency ultrasound of 2 MHz, 3MHz or higher may be used by the described embodiments to heat theeyelid and meibomian glands. Alternatively, a normal frequencytherapeutic ultrasound may be used at a higher power setting or a longerduration to generate sufficient heat. The use of therapeutic ultrasoundmay help emulsify blocked fats by two distinct example mechanisms. Forexample, the high frequency ultrasound may provide heat energy to fatsin the gland. The heat energy delivered may liquefy solidified fats. Theoscillations would further act to mobilize oil movement through theformation of small bubbles in the oil medium. This may be referred to asmicrocavitation. Accordingly, the use of therapeutic ultrasound may heatthe gland to liquefy fat blockage and create microcavitation. Ultrasoundenergy may further facilitate movement of oil within the glands and/orductules through acoustic streaming. The therapeutic ultrasound may alsostimulate circulation in the eyelid and meibomian gland, which maypromote clearance of inflammatory mediators. Further, the therapeuticultrasound may help breakdown and remodel scar tissue in the eyelid,which may be the result of a chalazion, or other trauma orinfection/inflammation to eyelid. Therapeutic ultrasound may be usedpost-surgically on the eyelid to reduce scar formation and facilitatehealing of tissue after eyelid surgery. These eyelid surgeries couldinclude but would not be limited to blepharoplasty, ptosis repair,entropion repair, ectropion repair, excisional and incisional biopsiesand so on. When used to remodel scar tissue therapeutic ultrasound couldbe combined with other treatments such as intralesional injection ofcorticosteroids or topical application of steroids and otheranti-inflammatories. In this situation therapeutic ultrasound mayfacilitate penetration of and distribution of medications.

Alternatively, or in conjuction with being directed on the meibomianglands, ultrasound energy could be directed superotemporally in theorbit to focus energy on the lacrimal gland. This acoustic energy maystimulate secretion of tears from the lacrimal gland through to thelacrimal ducts.

In addition to aforementioned applications of therapeutic ocularultrasound, if the power and frequency settings are varied, ultrasoundenergy may be directed medially at the nasolacrimal duct apparatus toresolve partial and complete blockages. Ultrasound energy can be used toresolve blockages of the upper and lower canalaculi, the lacrimal sac,or the nasolacrimal duct itself. The ultrasound could be used at lowersettings to facilitate flow through the entire apparatus in partialblockages or functional blockages. The ultrasound may be used at higherenergy settings to break up stones if they are obstructing the passages.This technique may be directed to stones located anywhere along theentire course of the nasolacrimal system. This ultrasound method may beanalogous to the lithotripsy used for treatment of kidney stones. Asmall probe attachment may be used for this application as it wouldallow the clinician to focus or broaden ultrasound energy around thedesired location.

Referring now to FIG. 1 there is shown a system using therapeuticultrasound for eye conditions. The system 10 is operable to connect atransducer head 16 to an ultrasound machine 12 via connector 18. Thetransducer head 16 may be shaped to complement various portions of theeye. Further, the transducer head may include a small probe attachmentsized proportional to the portion of the eye to be treated in order tofocus or broaden energy on the specific treatment portion of the eye.The transducer head 16 may also include a piezoelectric crystal 14 ornumerous crystals as a non-limiting illustrative example. Other exampletransducer heads 16 are electromagnetic transducers, and so on. In thisillustrative example, the system 10 is operable to deliver electricitythrough the ultrasound machine 12 to the piezoelectric crystals 14encapsulated in the transducer head 16 coupled to the closed eyelid 24.A gel 20 may be used as a coupling medium to allow direct contact of thetransducer head to the closed eyelid 24. The ultrasound machine 12 mayoperate at a high frequency, such as 2 MHz or higher, for example. Alower frequency at a higher power (or amplitude) may also be used. Thedelivery of ultrasound energy may be continuous or pulsed. Pulsed energymay allow for a slower heat rise than continuous ultrasound energy atthe same intensity. A pulsed ultrasound application may take longer towarm the tissue but may provide a larger safety margin and reduce chanceof tissue burn.

The ultrasound machine 12 is configured for treatment of an eyecondition, such as dry eye, dysfunction of the meibomian gland, lacrimalgland, periocular gland, and nasolacrimal system, chalazion, andscarring. The ultrasound transducer 16 is adapted for eye treatment andsuitable for coupling to at least a portion of an eyelid to supplyultrasound waves to the eyelid according to treatment parameters. Thetreatment parameters may include a frequency, an amplitude (e.g. power),an on/off cycle (e.g. for pulses), a phase, and a treatment period. Anexample treatment frequency range is between 1 MHz and 5 MHz, andfurther examples are provided herein. The treatment parameters mayspecify a range of frequencies and amplitudes for the ultrasound waves.The ultrasound machine 12 may also be connected to a temperaturemeasurement device (e.g. measurement tool 25 of FIG. 5) that isconfigured to measure temperature elevations induced by deposition ofacoustic energy to the eyelid by the ultrasound transducer 16. If thetemperature increases above the range a warning alert may be generatedto adjust the treatment parameters or the transducer 16 may be shut downautomatically to avoid damage to the eye or eyelid. If the temperaturedecreases below the range an alert may be generated to adjust thetreatment parameters. An example temperature measurement device may be athermocouple. A measurement device may also measure ultrasound waves andprovide the measurement data to ultrasound machine 12. If the ultrasoundwaves pass a predetermined safety threshold then then transducer 16 mayautomatically shut down or adjust to stay within the safety threshold.An example measurement device for ultrasound waves is a hydrophone.

The frequency range may provide sufficient ultrasound energy to heat thetreatment area of the eye. For example, the frequency range of 2 MHz to5 MHz may provide sufficient ultrasound energy to heat the treatmentarea of the eye to 40 degrees Celsius. Tissue denaturation may start attemperatures well over 45 when applied for long treatment periods, suchas over 100 minutes. The treatment period may be proportional to thetreatment frequency, as a lower frequency may require a longer periodand vice versa. Example treatment periods range between thirty secondsto twenty minutes, one minute to ten minutes, and two to five minutes.These are non-limiting example treatment periods and others may be used.

The eye condition may be caused by lipids blocked in a gland of the eyeand the ultrasound waves may heat the treatment area of the eyelid toemulsify the lipids blocked in the gland. As noted herein, theultrasound waves may supply oscillations to move the emulsified lipidsby creating bubbles in the emulsified lipids, may supply acousticstreaming to mobilize the emulsified lipids, may cause mircocavitationto mobilize the emulsified lipids, stimulate circulation in the areaproximate to the portion of the eyelid, and breakdown scar tissue in thearea proximate to the portion of the eyelid.

The ultrasound machine 12 may include a controller to receive treatmentdata from a data source (e.g. computing system 32 or other third partynetworked system). The controller may process the treatment data todetermine the treatment parameters and direct the ultrasound transducer16 to propagate ultrasound waves according to the treatment parameters.The treatment data may define eye condition, measurements, location, andso on. The ultrasound machine 12 may also connect to an ultrasoundimaging camera. The ultrasound machine 12 is operable in a therapeuticmode to heat the area proximate to the portion of the eyelid. Theultrasound machine 12 is operable in a diagnostic mode to image the areaproximate to the portion of the eyelid using the ultrasound imagingcamera. The diagnostic mode may be used to collect treatment dataregarding the eye condition.

The system 10 may also include a roller 26 to express oil secretionsfrom the meibomian glands. The roller 26 may have various shapes, suchas a curve or concave shape to complement the eye.

The piezoelectric crystal 14 may be a PZT-8 or similar material, or mayuse other techniques such as electromagnetic. The ultrasound machine 12may be powered by various means such as by a standard current or aninternal battery. The transducer head 16 may be a plastic materialforming a sealed transducer, a head cover, and so on. The transducerhead 16 may have various shapes and components, such as a curved orconcave shape complementary to eyelid, elliptical shape, a flat head,thin plates extension, probe attachments, and so on. The piezoelectriccrystal 14 may contract and expand based on the ultrasonic frequencysignals supplied by the ultrasound machine 12 to generate ultrasonicpressure waves which are coupled to the closed eyelid 24 via transducer16. Any oscillating component with a transducer head 16 may provideultrasound energy through the probe to the eyelid, meibomian glands,lacrimal gland, periocular glands or nasolacrimal system. Thetransmission of the pressure waves into the closed eyelid 24 may beenhanced by the gel 20. The ultrasonic pressure waves propagate throughthe closed eyelid 24 to the meibomian glands, lacrimal gland, periocularglands or nasolacrimal system. Transducer 16 may be held in place by anadhesive, a clip, or by a health assistant for a treatment period. Whenthe treatment is applied by a health assistant the probe may be slowlymoved over the closed eyelid 24. Moving the transducer head 16 duringtreatment may be important because of the following effects: to smoothout irregularities of the near field, to minimize hotspot formation, toreduce irregularities of absorption that might occur due to reflection,interfaces, standing waves, refraction, and differences in tissuethermal conduction or blood flow. It is estimated that at an output 1W/cm2 there is a rise of 0.8 C/min if vascular cooling effects areignored.

Alternatively, instead of the transducer head 16 being moved by theclinician over the tissue of the eyelid 24, the transducer head 16 maybe stationary or fixed to the eyelid 24. If mobile, a ultrasoundtransducers could be employed and this may have a single active elementthat both generates and receives high frequency sound waves, or twopaired elements one for transmitting and one for receiving. In contrast,if stationary, a head 16 with multiple components could vary theultrasound beam applied from the transducer.

The transducer head 16 may have moving components within the head thatvary the ultrasound beam applied from the transducer 16.

A phased array may be used to vary the application of the ultrasoundacross the treatment field. This may allow the clinician to simply applythe transducer 16 (or probe attached thereto) to the eyelid 24 orfasten/adhere it in place without constantly moving the transducer 16(or probe attached thereto). With this phased array the risk of having astanding wave or a hotspot may be greatly reduced. The phased arraycould be arranged in a strip (linear array), a ring (annular array), acircular matrix (circular array), or a more complex shape such as anellipse that would conform to the shape of the eyelids.

Ultrasound energy may be passed into the ocular tissues, which mayincite inflammation and potentially cause cataract formation. Inaccordance with embodiments described herein, systems, methods and usesmay involve a vaulted scleral contact lens 22. The lens 22 may be placedover the eye globe and under the eyelids 24 to form a chamber of airbetween the posterior surface of the contact lens and the cornea itself.Since ultrasound energy does not pass well through gases this vaultedchamber would act as a barrier to ultrasound transmission effectivelyshielding the eye from the ultrasound energy. Alternatively, a lensspeculum may be applied to the eye to elevate eyelid 24 from eye globeand create an airspace between eye globe and eyelid 24.

The system 10 may also include a display for displaying images and videofrom ultrasound machine 12 and a computing system 32 with a processorand memory 34 for processing captured data, images and video. Thecomputing system 32 and may be operable to store data/images/video inmemory 34 and/or an imaging database 36. The transducer 16 may have animaging component 28. The ultrasound 12 and transducer 16 may be used ina diagnostic setting to image the gland and eyelid 24, as well as atherapeutic setting to heat the eyelid 24 and gland. The gland andsurrounding tissues could be imaged in real time as the treatment isprovided by the transducer head 16.

Referring now to FIG. 2 there is shown a diagram of a meibomian glandand duct 40, with a fat blockage 44. There is also shown an illustrativeview of the meibomian gland and duct 40. As shown the meibomian glandand duct 40 may be located in the eyelid 24 near the eye globe 42.

The transducer 16 may be applied to eyelid at different angles anddirections. Referring now to FIG. 3 there is shown uses of therapeuticultrasound for eye conditions. In one example, a transducer head 16 mayhave a curved shape to complement the eyelid 24. The transducer head 16may propagate ultrasound waves towards the eyelid 24 and eye globe 42 toliquefy fat blockage 44 in the gland 40. A lens 22 may create a chamberof air 46 to protect eye globe 42. The lens 22 may be placed over theeye globe 42 and under the eyelids 24 to form a chamber of air 46between the posterior surface of the contact lens 22 and the corneaitself. The contact lens could also be made of an absorptive materialthat doesn't allow penetration of ultrasound energy. In this case thecontact lens would form a sufficient barrier so that it would not needto be vaulted off the globe. Alternatively, a lens speculum (not shown)may be applied to the eye to elevate eyelid 24 from eye globe 42 andcreate an airspace between eye globe and eyelid 24. In another example,the transducer head 16 may propagate ultrasound waves away from the eyeglobe 42 using thin plates which form part of transducer head 16.

Referring now to FIG. 5 there is shown another diagram of a use oftherapeutic ultrasound for eye conditions. The transducer head 16 mayhave a curved shape to complement the eyelid 24. The transducer head 16may propagate ultrasound waves towards the eyelid 24 and eye globe 42. Alens 22 may be positioned on top of the cornea and covered by the eyelid24. The lens 22 may be vaulted to protect eye globe 42 by creating achamber of air between the posterior surface of the contact lens 22 andthe cornea itself. The contact lens could also be made of an absorptivematerial that doesn't allow penetration of ultrasound energy. In thiscase the contact lens would form a sufficient barrier so that it wouldnot need to be vaulted off the globe. Coupling gel 23 may be applied ontop of the eyelid 24 to act as a coupling medium between the tissue andthe transducer 16. Ultrasound waves will be transmitted by thetransducer 16 into the eyelid 24. A temperature and attenuationmeasurement device may be positioned proximate to the lens or other areato collect and record temperatures and attenuation measurements tomonitor heating of eye 42. For example, a measurement tool 25 may bepositioned on the lens 22 in order to take temperature measurements. Themeasurement tool 25 may be a thermocouple. The measurement tool 25 mayprovide temperature data to controller. If the temperature exceeds asafety threshold the controller may automatically shut off thetransducer 16 to ensure the eye 42 is not damaged, automatically adjustthe treatment parameters to reduce the temperature, or send an alertnotification. The measurement tool 25 may be positioned on the lens 22using glue or other adhesive. It may also be built within the lens 22.

Referring now to FIG. 4 there is shown a method 100 using high frequencyultrasound for eye conditions. The method 100 may be use high frequencyultrasound to liquefy solidified fats in the meibomian gland, or otherglands/ducts. At 102, a clinician may administer a drop of tetracaine orequivalent topical anesthetic unto the eye. At 104, a scleral shieldlens 22 may be placed onto the eye. At 106, the ultrasound transducer 16propagating the high frequency ultrasound waves (such as 3 MHz) may thenbe applied to both closed eyelids 24 through a coupling gel 20 mediumfor a treatment period, such as for example a two to five minutestreatment for each eye. After the heating treatment, at 108, amechanical roller may be used to express oil secretions from themeibomian glands. This may occur while the contact lens shield is stillin place. For example, this roller may be applied from a proximal todistal direction in the direction of the meibum flow within the glandsthemselves. Alternatively, a cotton swap (e.g. Q-tip) or otherinstrument may be used to guide oil. Post treatment, the patient may beplaced on a short course of topical steroids (or NSAIDs) to minimize anypost-procedural inflammation.

Referring now to FIG. 6, there is shown a diagram of a use oftherapeutic ultrasound with an attachment for eye conditions accordingto some embodiments. The attachment 52 may couple to the transducer 16in order to propagate ultrasound waves to the eyelid 24. The attachment52 may include a protective portion 50 shaped to complement the eye 42and protect the eye 42 from the ultrasound waves. The attachment 52 andprotective portion 50 may clip onto the patient's head or eye 42 (orotherwise attach) for the duration of the treatment period.

Referring now to FIG. 7, there is shown another diagram of a use oftherapeutic ultrasound with an attachment for eye conditions accordingto some embodiments. The attachment 56 may couple to the transducer 16in order to propagate ultrasound waves through the eyelid 24 but awayfrom eye globe 42. The attachment 56 is shaped to complement the eye 42and eye lid 24 and position therebetween. In this example, theultrasound waves propagate away from the eye 42 to reduce chance of harmdue to heat. This may protect the eye 42 from the ultrasound waves. Theattachment 56 may clip onto the patient's head or eye 42 (or otherwiseattach) for the duration of the treatment period.

Embodiments have been described by way of example only, and variousmodification and variations may be made to these exemplary embodiments.

1-36. (canceled)
 37. A system for treating an eye condition comprising:an ultrasound device comprising at least one ultrasound transducer forcoupling to at least a portion of an eyelid to supply ultrasound wavesto an area proximate to the portion of the eyelid according to treatmentparameters; and a contact lens to protect ocular tissue around the eye.38. The system of claim 37, wherein the treatment parameters comprise afrequency, an amplitude, on/off cycle, and a treatment period.
 39. Thesystem of claim 37, further comprising a controller operable forreceiving treatment data from an external source, determining thetreatment parameters based on the treatment data, and directing theultrasound transducer according to the treatment parameters.
 40. Thesystem of claim 37, wherein the ultrasound waves heat the area proximateto the portion of the eyelid. 41-44. (canceled)
 45. The system of claim37, wherein the eye condition is caused by lipids blocked in a gland orduct of the eye and wherein the ultrasound waves heat the area proximateto the portion of the eyelid to emulsify the lipids blocked in the glandor the duct and facilitate flow. 46-49. (canceled)
 50. The system ofclaim 37, whereby the ultrasound waves perform at least one of thefollowing: stimulating circulation and lymph flow in the area proximateto the portion of the eyelid; breaking down scar tissue in the areaproximate to the portion of the eyelid; supplying continuous ultrasoundenergy; and supplying pulsed ultrasound energy. 51-53. (canceled) 54.The system of claim 37, wherein the device further comprises a probe forcoupling to the ultrasound transducer.
 55. The system of claim 37,wherein the device is configured to provide phased array ultrasound. 56.The system of claim 37, wherein the ultrasound transducer comprisesmovable components that are configured to move relative to the portionof the eyelid to vary ultrasound waves.
 57. The system of claim 37,where in the device comprises an ultrasound imaging camera and whereinthe device is operable in a therapeutic mode to heat the area proximateto the portion of the eyelid using the ultrasound waves and a diagnosticmode to image the area proximate to the portion of the eyelid using theultrasound imaging camera.
 58. The system of claim 37, wherein theultrasound transducer has a concave shape or an elliptical shape tocomplement the eyelid.
 59. (canceled)
 60. The system of claim 37,wherein the device further comprises an attachment for the ultrasoundtransducer, wherein the attachment comprises a protective portion forpositioning over the eye globe and under the eyelid to protect eyetissue, wherein the protective portion has a concave shape to complementthe eyelid. 61-63. (canceled)
 64. The system of claim 37, wherein thelens is a vaulted scleral contact lens configured for placement over theeye globe and under the eyelid to form a chamber of air between theposterior surface of the contact lens and the cornea.
 65. The system ofclaim 37, wherein the lens comprises an absorptive material to blockpenetration of ocular tissue by the ultrasound waves.
 66. The system ofclaim 37, further comprising a lens speculum to elevate the eyelid fromthe eye globe and create an airspace between eye globe and eyelid. 67.The system of claim 37, further comprising a temperature measurementmechanism for measuring the temperature of the area proximate to theportion of the eyelid.
 68. The system of claim 67 wherein thetemperature measurement mechanism comprises a thermal couple.
 69. Thesystem of claim 68, wherein the thermal couple is positioned on orwithin the contact lens.
 70. The system of claim 37, further comprisingan ultrasound measurement mechanism for measuring the ultrasounds wavesat the area proximate to the portion of the eyelid.
 71. A method fortreating an eye condition using a therapeutic ultrasound device, themethod comprising: coupling at least one ultrasound transducer to atleast a portion of an eyelid; propagating ultrasound waves to an areaproximate to the portion of the eyelid using the ultrasound transduceraccording to treatment parameters; and placing a contact lens over theeye globe and under the eyelid to protect ocular tissue around the eye.72. The method claim 71, wherein the treatment parameters comprise afrequency, an amplitude, on/off cycle, and a treatment period. 73.(canceled)
 74. The method of claim 71, wherein the lens is a vaultedscleral contact lens configured to form a chamber of air between theposterior surface of the contact lens and the cornea.
 75. The method ofclaim 71, wherein the lens comprises an absorptive material to blockpenetration of ocular tissue by the ultrasound waves.
 76. The method ofclaim 71, further comprising using a lens speculum to elevate the eyelidfrom the eye globe and create an airspace between eye globe and eyelid.77. The method of claim 71, wherein the eye condition relates to themeibomian glands and wherein the ultrasound waves are supplied for thetreatment period to liquefy solidified fats in the meibomian glands. 78.The method of claim 71, wherein the eye condition relates to the glandsof Zeiss with a hordeolum present and wherein the ultrasound waves aresupplied for the treatment period to liquefy fats in the glands of Zeisswhen the hordeolum is present.
 79. The method of claim 71 furthercomprising applying ultrasound gel to the surface of the eyelid to actas a coupling medium between eye tissue and the ultrasound transducer.80-85. (canceled)